Hard capsule and method for producing same

Abstract

This invention provides a hard capsule that has excellent stability even when filled with a solvent for dissolving poorly soluble drugs, and that also achieves reduction in disintegration time, thereby ensuring excellent solubility.Specifically, the hard capsule of the present invention has a film comprising:(A) a polymer or copolymer obtained by polymerizing or copolymerizing, in the presence of polyvinyl alcohol and / or a derivative thereof, at least one polymerizable vinyl monomer represented by Formula (1):H2C═C(R1)—COOR2  (1)wherein R1 represents hydrogen or methyl, and R2 represents hydrogen or alkyl having 1 to 4 carbon atoms; and(B) native gellan gum.

Description

[0001]The present invention relates to a hard capsule comprising a film, which comprises a copolymer and a specific compound. The copolymer is obtained by copolymerizing polyvinyl alcohol and / or a derivative thereof and at least one polymerizable vinyl monomer. The present invention also relates to a production method of the hard capsule.BACKGROUND ART[0002]Many of the active substances of medicines, i.e., pharmaceutical active ingredients, have poor water solubility. Such substances are poorly absorbed from the alimentary tract, and the bioavailability and drug efficacy expression are easily reduced or are subject to fluctuation. For this reason, in preclinical tests that evaluate drug efficacy or obtain biopharmaceutical parameters using lab animals or the like, the pharmaceutical active ingredients are often dissolved in some solvent to make them more easily absorbed. For a poorly soluble pharmaceutical active ingredient, it is possible to use a polyethylene glycol having relativ...

AI Technical Summary

Benefits of technology

[0043]The hard capsule of the present invention has excellent stability even when filled with a solvent for dissolving poorly soluble drugs, and also ensures excellent solubility, thereby reducing disintegration time. The hard capsule of the present invention also has excellent mechanical strength and suppresses film softening in a low-humidity environment. Furthermore, the hard capsule of the present invention maintains a low moisture content.

[0044]The present invention provides a hard capsule that can be filled with various types of pharmaceutical active ingredients previously considered unsuitable to be encapsulated, and that has excellent mechanical strength during storage. This enables various types of drugs (including poorly soluble drugs) to be encapsulated into hard capsules. Further, since the hard capsule of the present invention has excellent stability even when filled with a solvent for dissolving poorly soluble drugs, it contributes to, for example, improvement in capsule quality.

[0045]Further, by adopting the method of specifying the pH of the starting solution for capsule preparation to 2 to 6 and drying the starting solution in the form of a capsule, it is possible to obtain a hard capsule with further improved mechanical strength.

Problems solved by technology

Many of the active substances of medicines, i.e., pharmaceutical active ingredients, have poor water solubility.

Such substances are poorly absorbed from the alimentary tract, and the bioavailability and drug efficacy expression are easily reduced or are subject to fluctuation.

However, these solvents are usually in liquid form and not easily processed into tablets.

However, because of the low solubility of polyvinyl alcohol particularly under a low temperature, it takes a long time to dissolve this hard capsule.

Therefore, the capsule was not suitable to contain, in particular, medicaments that must be quickly absorbed.

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